Incyte has announced that its Phase III DEVENT study of ruxolitinib for treating patients on mechanical ventilation with Covid-19 associated Acute Respiratory Distress Syndrome (ARDS) failed to meet its primary endpoint.
ARDS is a condition where fluid builds up in the air sacs of the lungs, resulting in inflammation.
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The randomised, double-blind, placebo-controlled, multicentre clinical trial was designed to assess the safety and efficacy of ruxolitinib (5mg and 15mg) plus standard of care (SoC) compared to SoC plus placebo in patients with Covid-19 associated ARDS on mechanical ventilation.
The primary endpoint was determining the mortality rate at day 29 among patients administered with ruxolitinib 5mg twice daily plus SoC therapy, ruxolitinib 15mg, plus SoC compared with placebo plus SoC.
The results indicated an improvement in mortality rate compared to placebo, however, the data was not statistically significant.
Furthermore, the analysis of the study identified clinically and statistically significant improvement in mortality in 5mg and 15mg treatment arms among US study population.
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By GlobalDataParticipants from the US accounted nearly 91% of the total study population.
A post-hoc analysis also found statistically significant improvement in mortality in both the study arms.
Incyte chief medical officer Steven Stein said: “There remains a significant unmet medical need for treatments that may potentially improve survival outcomes for patients suffering from severe Covid-19 related complications, specifically those requiring mechanical ventilation.
“We hope the results of this study, and the potential utility of ruxolitinib for treatment of patients with severe Covid-19 associated ARDS, will contribute to the advances being made across the scientific community to alleviate the burden this pandemic has placed on patients, as well as the healthcare system.
“We look forward to discussing the results of the DEVENT study with regulatory authorities in the US.”
